Manufacturer
Eiken
JapanLegal entities : EIKEN CHEMICAL CO., LTD.
Markets : Belgium · France · Germany · Italy · Netherlands · Northern Ireland · Norway · United States
Approvals : EU – class A, C · United States (FDA) – 510(k) : 4 · class I, II · latest in 2020 · see on the FDA website
EU representative : Human Gesellschaft für Biochemica und Diagnostica mbH (Germany)
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
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| Category | EMDN code | Registered models | Class | Contact |
|---|---|---|---|---|
| Plasmodium (malaria) | W0105050209 | C IVDR | EUDAMED record Report an error | |
| Faeces collection devices | W05019001 | A IVDR | EUDAMED record Report an error | |
| Automated immunochemistry analysers - moderate routine (throughput > 100 and <= 250 test/h) | W0201020102 | A IVDR | EUDAMED record Report an error | |
| Mycobacterial detection by NA reagents | W0105010703 | C IVDR | EUDAMED record Report an error | |
| Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus | W0105900101 | A IVDR | EUDAMED record Report an error |
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